MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY 200; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	1032800
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/07/2016
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information from a third party service center alleging a ventilator's active exhalation control valve remained open.There was no report of patient harm or injury.The device has not yet been evaluated by the manufacturer.At this time, we are unable to confirm the alleged malfunction.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer has completed the evaluation of a ventilator with the allegation of the device's active exhalation control valve remained open.During the evaluation of the device at the manufacturer's service center.The customer's complaint was not confirmed.During the evaluation of the device, an issue with the device's sensor board was observed.The sensor board was replaced to address the issue.

• Brand Name: TRILOGY 200
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 5476611
• Report Number: 2518422-2016-00996
• Device Sequence Number: 401654
• Product Code: CBK
• UDI-Device Identifier: 00606959022829
• UDI-Public: 606959022829
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K093416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1032800
• Device Catalogue Number: 1032800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2016
• Supplement Report FDA Received Date: 05/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1